| Primary Device ID | 10827002140568 |
| NIH Device Record Key | 0ab87453-0465-45ba-89b6-8a7635e6d4fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rutner |
| Version Model Number | G14056 |
| Catalog Number | 026104 |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002140561 [Primary] |
| GS1 | 10827002140568 [Package] Contains: 00827002140561 Package: [10 Units] In Commercial Distribution |
| KOD | CATHETER, UROLOGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-09-24 |
| 00827002152618 | Rutner Suprapubic Balloon Catheter Set |
| 00827002150706 | Rutner Suprapubic Balloon Catheter Set |
| 00827002149205 | Rutner Suprapubic Balloon Catheter Set |
| 00827002146815 | Rutner Balloon Dilation Helical Stone Extractor |
| 00827002145474 | Rutner Balloon Dilation Helical Stone Extractor |
| 00827002145405 | Rutner Balloon Dilation Helical Stone Extractor |
| 00827002145399 | Rutner Balloon Dilation Helical Stone Extractor |
| 00827002143142 | Rutner Balloon Dilation Helical Stone Extractor |
| 00827002142633 | Rutner Balloon Dilation Helical Stone Extractor |
| 10827002140575 | Rutner Universal Wedge Catheter |
| 10827002140568 | Rutner Universal Wedge Catheter |
| 00827002261242 | Rutner Balloon Dilation Helical Stone Extractor |
| 00827002173200 | Rutner Suprapubic Balloon Catheter Set |
| 00827002173194 | Rutner Suprapubic Balloon Catheter Set |
| 00827002165670 | Rutner Suprapubic Balloon Catheter Set |
| 00827002165663 | Rutner Suprapubic Balloon Catheter Set |
| 00827002165656 | Rutner Suprapubic Balloon Catheter Set |
| 00827002161986 | Rutner Suprapubic Balloon Catheter Set |